MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED AKREOS AO LENS (RIGHT EYE); INTRAOCULAR LENS

Model Number M160L

Patient Problems Visual Impairment (2138); Anxiety (2328)

Event Date 05/08/2013

Event Type  Injury  

Event Description

Reporter called to inform the fda that her implanted lenses in both right ((b)(6) 2013) and left ((b)(6) 2013) eyes have been recalled since 2014 and she was never informed of the recall.She learned about the recall today.To no avail, reporter stated that she informed the doctor immediately after being implanted that her vision was worse than what it was before, for both eyes.The implanted lenses have always given her problems with her vision but has escalated in the past year.Reporter stated that the recalled lenses are due to incorrect "raw material" used to manufacture the lenses and she would like to know more specifically what that entails and if it can cause loss of vision in the long term.Reference report: mw5151153.

• Brand Name: AKREOS AO LENS (RIGHT EYE)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 18667414
• MDR Text Key: 335069046
• Report Number: MW5151152
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: M160L
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female